|
Device | MEDTRONIC SYNCHROMED PUMP AND INFUSION SYSTEM (SYNCHROMED EL AND SYNCHROMED II) |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P860004 |
Supplement Number | S090 |
Date Received | 06/22/2007 |
Decision Date | 11/10/2008 |
Product Code |
LKK |
Advisory Committee |
General Hospital |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE SOFTWARE CHANGES MADE TO THE SYNCHROMED EL AND SYNCHROMED II APPLICATION SOFTWARE LOCATED ON MODEL 8870 APPLICATION CARD. |